An ALLG phase II trial of Epcoritamab consolidation in high genomic risk and MRD+ CLL patients after first-line venetoclax + obinutuzumab [MOONSHOT] (ACTRN12625000387426)

This study investigates the safety and effectiveness of treatment with epcoritamab (Epkinly) following venatoclax-obinutuzumab in previously untreated patients with a type of CLL, which has at increased risk of disease coming back after treatment including: those with detectable MRD (measurable residual disease - an accurate test to detect very small amounts of CLL or SLL) following frontline ven-obi, or those with high-risk CLL genomics (changes in the genetic code in the CLL cells that are known to lead to the disease coming back sooner after completing ven-obi). The study compares outcomes to previously published clinical trial data from patients treated with ven-obi alone.

Trial phase

Phase 2

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof Constantine Tam

Key inclusion data

Inclusion criteria: CLL or SLL, after completion of first line venetoclax + obinutuzumab Received 12 cycles of venetoclax, at a dose of at least 100mg/day. Exclusion criteria: Received prior systemic therapy for CLL/SLL. Developed disease progression by IWCLL criteria during or following completion of venetoclax therapy.